According to the phase 2 EPIC-A trial, cemiplimab plus platinum-based chemotherapy showed both safety and efficacy for patients with locally advanced or metastatic penile carcinoma.

These results were first reported by Amit Bahl, MD, Bristol Hematology and Oncology Center, at the 2025 American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium.

This phase 2, non-randomized, multicenter trial enrolled 29 patients with locally advanced or metastatic penile carcinoma not amenable for radical treatment. Patients received 350 mg cemiplimab on day 1 every 3 weeks, plus standard-of-care chemotherapy (cisplatin/fluorouracil, n = 27; or docetaxel, ifosfamide, cisplatin, n = 2) for 4 cycles, followed by 350 mg cemiplimab alone every 3 weeks for up to a total of 34 cycles. The primary end point of this study was investigator-assessed clinical benefit rate (CBR) at 12 weeks.

With a median follow-up duration of 8.3 months, the 12-week CBR was 62.1%. The 12-week objective responsive rate (ORR) was 51.7%, with 15 partial responses and no complete responses. The 21-week CBR was 48.3% and 21-week ORR 44.8%, with 12 partial responses and 1 complete response. The median progression-free survival was 6.2 months, and the overall survival is currently estimated at 15.5 months.

There were 23% of adverse events of any grade related to cemiplimab, and 30% related to chemotherapy. There were no unexpected adverse events reported. There were 2 grade 5 adverse events (none related to cemiplimab, 1 related to chemotherapy). Of the 7 patients who discontinued treatment due to adverse events, 4 were related to cemiplimab.

Dr Bahl and coauthors concluded that these data “support cisplatin-based combination chemotherapy [plus] cemiplimab as a first-line [standard-of-care] treatment option in this rare cancer.”

Source:

Bahl A, Challapalli A, Venugopal B, et al. EPIC-A: Phase II trial of cemiplimab plus standard of care chemotherapy followed by maintenance cemiplimab in locally advanced or metastatic penile carcinoma. Presented at 2025 ASCO Genitourinary Cancers Symposium. February 13-15, 2025; San Francisco, CA. Abstract 1.